510(k) K141452

LEFORTE NEURO SYSTEM BONE PLATE AND SCREW by Jeil Medical Corporation — Product Code GWO

K141452 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LEFORTE NEURO SYSTEM BONE PLATE AND SCREW". The FDA issued a decision of Substantially Equivalent on Jul 2, 2014. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Jeil Medical Corporation has 52 other 510(k) clearances on record.